Long-Term Criminal Fraud at Pfizer and Ranbaxy – An Indian Company That Makes Generic Lipitor
Pfizer failed to warn people about Lipitor’s related risks of type-2 diabetes. The drug was approved by the FDA in 1996. On Wednesday, September 2, 2009, the American pharmaceutical giant, Pfizer, agreed to plead guilty to a felony violation of the Food and Drug Act and to pay $2.3 billion to resolve criminal and civil liability arising from its illegal promotion of certain products such as Bextra, Zyvox, Lyrica and Geodon.
In 2012, the FDA issued a notice ordering Pfizer, manufacturer of Lipitor, to add box warnings about the risks of diabetes. The warning came years too late. Millions of people used the drug in the United States and many of them now suffer the type 2-diabetes as a result.
Many plaintiffs filed Lipitor claims in April 2013 and asked the United States Judicial Panel on Multidistrict Litigation to transfer the Lipitor cases to the District of South Carolina. The panel approved and established the Lipitor Multidistrict Litigation which included about 300 cases in February, 2014.
FDA Investigators Found Ranbaxy Corrupt to its Core
About eighty percent of all medicines prescribed in the United States are generic drugs. More than forty percent of these drugs are made in countries such as India and China where the United States oversight is weaker. Ranbaxy pledged to the FDA that it would strictly operate within regulations.
In 2008, the FDA blocked thirty Ranbaxy drugs from coming into the United States from two Indian plants. However, Ranbaxy continued to sell their products in the United States from other facilities.
The company used brand name medicines as a substitute for its own testing. Some of Ranbaxy’s employers were used as drug mules. Malvinder Singh, the company’s head of pharmaceuticals, got involved. Letters claiming the products were for research and development were given to those who carried the drugs for Ranbaxy.
The FDA was investigating Ranbaxy for serious criminal violations, yet approved exclusive rights to the same company in November, 2011, to make a version of Lipitor. In the first six months, this privilege allowed the company to earn $600 million in sales of the generic Lipitor.
In 2012, glass particles in raw ingredients for generic Lipitor were found, and the company issued a recall. During the same year, inspectors from the FDA found faulty cleaning records and a failure to investigate problems. Despite the ongoing manufacturing failures, the company still sold more than $1 billion worth of drugs to the United States in 2013.
Ranbaxy had a persistent pattern of submitting untrue statements and faked test results for FDA approval. A PowerPoint presentation by Ranbaxy’s head of research and development, Dr. Rajinder Kumar, astonished a silent boardroom by showing that the company falsified data and lied to regulators in more than forty countries.
Kumar resigned from Ranbaxy and wrote a letter to Lester Crawford, FDA’s commissioner, and alleged that the company was selling ineffective and untested drugs. Dr. Kumar asked Crawford to put a stop to this terrible crime. Mr. Nelson, one of the FDA investigators, said the culture of the company was corrupt to its core. Everywhere they looked; they found fraud.
Ranbaxy pleaded guilty to seven felonies in a United States court in May, 2013. The company also agreed to pay $500 million in penalties, fines and forfeitures. Ohm Laboratories in New Jersey, owned by Ranbaxy, is now the company’s only permitted maker of drugs in the United States.
The Dark Side of Statins
Atorvastatin, marketed by Pfizer under the trade name Lipitor, belongs to the drug class known as statins. In February 2012, the Food and Drug Administration ordered label warnings on statins, including Lipitor. Currently, several hundred lawsuits have been filed in the state and federal courts nationwide against the Lipitor manufacturer. In February 2014, the United States Judicial Panel on Multidistrict Litigation approved to consolidate and centralize all Lipitor cases. The cases have been placed before District Judge Richard M. Gergel in the District of South Carolina.
FDA warnings and studies indicate that Lipitor is linked to an increased risk of diabetes, memory loss and confusion. Another side effect that got a great deal of attention among doctors is muscle damage. Many patients taking statins have complained that the drugs make their shoulders and knees hurt. According to an ongoing data collection at the University of California, adverse effects of statins include muscle damage or myopathy.
Lipitor can have a substantial impact on a patient’s quality of life; therefore, Pfizer should be required to compensate users for failing to disclose information about the potential side effects of their drugs. The litigation process is a lengthy one and if Pfizer does not agree to settle Lipitor cases, they could face thousands of separate trials throughout America.
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